Recce Pharmaceuticals Ltd. has secured the final patent in its global intellectual property portfolio with the formal granting of a new patent by the China National Intellectual Property Administration. The patent, titled "Copolymer and Method for Treatment of Bacterial Infection," provides protection for the company's synthetic anti-infectives RECCE 327 and RECCE 529 until 2035.
Strategic Market Access in World's Second-Largest Pharmaceutical Market
The Chinese patent approval represents a significant milestone for the Australian biotechnology company, completing its comprehensive global patent protection strategy. China's pharmaceutical market, valued at approximately $140 billion in 2021, represents the world's second-largest market and continues expanding at an average annual growth rate of 3.2%.
"We thank the China National Intellectual Property Administration for their recognition of the significant potential of Recce's new class of anti-infectives," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. "We are proud to have completed our portfolio of family two patents and now have coverage globally until at least 2035."
The patent claims encompass methods of manufacture, administration, and application of RECCE 327 and RECCE 529 for treating a broad spectrum of common human infections. This intellectual property protection extends across all major pharmaceutical markets globally, including the United States, Europe, Japan, and Australia.
Novel Approach to Antibiotic Resistance
Recce's synthetic polymer anti-infectives represent a new class of treatments designed to address the urgent global health challenge of antibiotic-resistant superbugs and emerging viral pathogens. The company's pipeline includes three patented compounds: RECCE 327 for intravenous and topical therapy targeting serious bacterial infections, RECCE 435 for oral bacterial infection treatment, and RECCE 529 for viral infections.
The anti-infectives employ multi-layered mechanisms of action that potentially overcome the hypercellular mutation capabilities of bacteria and viruses, addressing a fundamental limitation of existing antibiotics. RECCE 327 targets both Gram-positive and Gram-negative bacteria, including their superbug variants.
Regulatory Recognition and Development Status
The U.S. Food and Drug Administration has awarded RECCE 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, qualifying it for Fast Track Designation and 10 years of market exclusivity post-approval. The compound has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world's only synthetic polymer and sepsis drug candidate in development.
Recce maintains wholly-owned automated manufacturing capabilities supporting current clinical trials. The company emphasizes that RECCE 327 is not yet market-approved for human use, with further clinical testing required to fully evaluate safety and efficacy.
Market Positioning and Growth Trajectory
China's pharmaceutical industry growth is driven by increasing healthcare demand, ongoing healthcare reforms, and substantial government support for pharmaceutical research and development. The market's continued expansion provides Recce with access to a substantial patient population and potential commercial opportunities for its novel anti-infective technologies.
The completion of Recce's global patent portfolio positions the company to pursue development and commercialization strategies across major international markets while maintaining intellectual property protection through 2035. This comprehensive coverage supports the company's efforts to address unmet medical needs in the treatment of resistant bacterial and viral infections.
